Patient Selection in a Pragmatic Study on the Management of Patients with Brain Arteriovenous Malformations.
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Raymond Jean, Benomar Anass, Gentric Jean-Christophe, Magro Elsa, Nico Lorena, Bacchus Emma, Klink Ruby, Iancu Daniela, Weill Alain, Roy Daniel, Bojanowski Michel W, Chaalala Chiraz, Eker Omer, Pelissou-Guyotat Isabelle, Piotin Michel, Aldea Sorin, Barbier Charlotte, Gaberel Thomas, Papagiannaki Chrysanthi, Derrey Stéphane, Nguyen Thanh N, Abdalkader Mohamad, Cognard Christophe, Januel Anne-Christine, Sabatier Jean-François, Jecko Vincent, Barreau Xavier, Costalat Vincent, Le Corre Marine, Gauvrit Jean-Yves, Morandi Xavier, Biondi Alessandra, Thines Laurent, Desal Hubert, Bourcier Romain, Beaujeux Rémy, Proust François, Viard Geraldine, Gevry Guylaine, Darsaut Tim E, TOBAS Collaborative Group
Аннотация
METHODS: The first randomized clinical trial (RCT-1) offers 1:1 randomized allocation of intervention versus conservative management for patients with arteriovenous malformation (AVM). The second randomized clinical trial (RCT-2) allocates 1:1 pre-embolization or no pre-embolization to surgery or radiosurgery patients judged treatable with or without embolization. Characteristics of RCT patients are reported and compared to registry patients.
RESULTS: From June 2014 to May 2021, 1010 patients with AVM were recruited; 498 patients were observed and 373 were included in the treatment registries. Randomized allocation in RCT-1 was applied to 139 (26%) of the 512 patients (including 127 of 222 [57%] with unruptured AVMs) considered for curative treatment. RCT-1 AVM patients differed (in rupture status, Spetzler-Martin grade and baseline modified Rankin Score) from those in the observation or treatment registries (P < 0.001). Most patients had small (<3 cm; 71%) low-grade (Spetzler-Martin I-II; 64%) unruptured (91%) AVMs. The allocated management was conservative (n = 71) or curative (n = 68), using surgery (n = 39), embolization (n = 16), or stereotactic radiosurgery (n = 13). Pre-embolization was considered for 179/309 (58%) patients allocated/assigned to surgery or stereotactic radiosurgery; 87/179 (49%) were included in RCT-2. RCT-2 patient AVMs differed in size, eloquence and grade from patients of the pre-embolization registry (P < 0.01). Most had small (<3 cm in 82%) low-grade (83%) AVMs in non-eloquent brain (64%).
CONCLUSIONS: Patients included in the RCTs differ significantly from registry patients. Meaningful results can be obtained if multiple centers actively participate in the TOBAS RCTs.